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Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination

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ClinicalTrials.gov Identifier: NCT01304303
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : October 21, 2016
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Brief Summary:
Phase I study of SPARC1023 alone and in combination with carboplatin

Condition or disease Intervention/treatment Phase
Solid Tumor in Advanced Stage Drug: SPARC1023 I Drug: SPARC1023 II Phase 1

Detailed Description:
Pharmacokinetic profile and dose escalation study of SPARC1023 when administered as 30-min infusion.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2011
Primary Completion Date : October 2016
Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: SPARC1023 I Drug: SPARC1023 I
IV administration
Experimental: SPARC1023 II Drug: SPARC1023 II
IV administration

Primary Outcome Measures :
  1. Determination of MTD [ Time Frame: One 21-day treatment cycle ]
    MTD for SPARC1023 in combination with carboplatin will be determined. MTD will be defined as the SPARC1023 dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects.

Secondary Outcome Measures :
  1. Establishing the pharmacokinetic profile [ Time Frame: One 21-day treatment cycle ]
    Plasma levels of SPARC1023 and Carboplatin will be determined and PK parameters viz. Cmax, AUC0-t, AUC 0-∞, MRT, Tmax, t½ , Kel, Vd for SPARC1023 in combination with carboplatin will be evaluated.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥18 years
  • ECOG Performance Status ≤ 1.
  • Estimated life expectancy of at least 12-weeks;
  • Measurable disease as per RECIST guideline (Version 1.1);

Exclusion Criteria:

  • Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in situ cervical cancer
  • Known hypersensitivity to the study drugs
  • Treatment with any anti-cancer agents within 28 days of study entry
  • Presence of clinically evident active CNS metastases, including leptomeningeal involvement, requiring steroid or radiation therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304303

United States, New York
SPARC Site 1
Buffalo, New York, United States
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT01304303     History of Changes
Other Study ID Numbers: CLR_10_23
First Posted: February 25, 2011    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by Sun Pharma Advanced Research Company Limited: